Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022219
Company: ENDO PHARMS INC
Company: ENDO PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AVEED | TESTOSTERONE UNDECANOATE | 750MG/3ML (250MG/ML) | INJECTABLE;INTRAMUSCULAR | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/05/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022219Orig1AveedTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/26/2022 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022219Orig1s019ltr.pdf |
06/28/2021 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022219Orig1s016ltr.pdf |
08/16/2021 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022219s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022219Orig1s015ltr.pdf | |
06/30/2020 | SUPPL-14 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022219Orig1s014ltr.pdf | |
03/13/2020 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022219Orig1s013ltr.pdf | |
12/19/2018 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s012ltr.pdf |
09/01/2018 | SUPPL-11 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s011ltr.pdf |
01/24/2018 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022219Orig1s010ltr.pdf | |
10/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022219s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022219Orig1s009.pdf | |
12/09/2016 | SUPPL-8 | REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022219Orig1s008ltr.pdf |
05/11/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022219Orig1s005.pdf | |
03/03/2015 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s003ltr.pdf | |
06/19/2014 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022219Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022219Orig1s001.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/16/2021 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022219s015lbl.pdf | |
06/30/2020 | SUPPL-14 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf | |
03/13/2020 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s013lbl.pdf | |
01/24/2018 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf | |
01/24/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022219s010lbl.pdf | |
10/25/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022219s009lbl.pdf | |
05/11/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s005lbl.pdf | |
03/03/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022219s003lbl.pdf | |
06/19/2014 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf | |
06/19/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s001lbl.pdf | |
03/05/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf |